FDA clears ConvaTec's continence control device
This article was originally published in Clinica
Executive Summary
ConvaTec's Vitala ostomy continence control device has received 510(k) approval from the US FDA. The product, designed for patients with an end colostomy, is a single-use disposable disc that is worn with the firm's Natura skin barrier. It allows patients to manage their colostomy without a pouch, belt or irrigation and can be used for up to eight hours. It seals against the opening in the intestine to prevent the release of stools, but allows gases to leave the body through a deodorising filter. Stools are removed via a built-in expandable container. Skillman, New Jersey-based ConvaTec plans to showcase the device at the WOCN/WCET meeting in Phoenix, Arizona in June, and launch it in the US "a few months" afterwards.
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